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FDA 510(k)

ECHO-PULSE KM555

K-Number: K821736 · 1982-12-09

ApplicantRabar, Inc.
Decision Date1982-12-09
Product CodeGXW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECHO-PULSE KM555 is the device name listed in this FDA 510(k) record. The listed applicant is Rabar, Inc.. It received FDA 510(k) clearance on 1982-12-09 under 510(k) number K821736. The device is classified under product code GXW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO-PULSE KM555?

ECHO-PULSE KM555 is a medical device that received FDA 510(k) clearance on 1982-12-09. The listed applicant is Rabar, Inc.. The 510(k) number is K821736.

When did ECHO-PULSE KM555 receive FDA 510(k) clearance?

ECHO-PULSE KM555 received FDA 510(k) clearance on 1982-12-09, under 510(k) number K821736.

Who is the listed applicant for ECHO-PULSE KM555?

The FDA 510(k) record lists Rabar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHO-PULSE KM555?

The FDA product code for ECHO-PULSE KM555 is GXW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rabar, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K844017MICROTENS 7757 T.E.N.S. STIMULATORK842414ECHO PULSE BURST

Related Devices (Code: GXW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K921863SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYSHewlett-Packard Co.K903085SMS-712NAToshiba America Medical Systems, In.CK8534325.0 IOP & 7.5 IOP PROBESDiasonics, Inc.K833522NEURO SECTOR FIXATION DEVICEAdvanced Technology Laboratories, Inc.K770788ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000Storz Instrument Co.K770575ECHOENCEPHALOGRAPH, DIGITAL, 1000Storz Instrument Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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